Friends Research Institute Human Subjects Enhancements

Friends Research Institute, Inc., Baltimore MD

Investigators

Abstract

This project to enhance human protections has five specific aims: (1) to develop an IRB and Adverse Event software tracking system (Pro_IRB) at the East coast Friends Research Institute, Inc. (FRI) site; (2) to allow additional training on Pro_IRB at the FRI Los Angeles site, where previously purchased software is not maximally effective; (3) to link East and West coast IRB software, to allow exchange, consolidation, and trending of data; (4) to develop and present Human Protections Workshops for new and established FRI Principal Investigators (PIs) and human subjects research staff, on the following topics: history of human subjects protections, participant's rights, Informed Consent, research Integrity, role of the IRB and Quality Improvement, special populations, and recent trends in human protections; and (5) to produce, distribute, and present a 5 to 10 minute VHS/CD-ROM/DVD program on the rights of research participants, "what to expect" while a participant, confidentiality, and the process of informed consent (with special emphasis on the voluntary nature of human research, and the "therapeutic myth"). This will be produced in Spanish and English, and will be required viewing at FRI for all prospective research participants, as well as PIs and staff. Copies and/or the master will be made freely available to any federal, state or other governmental entity. The tentative title is "Your Experience as a Research Participant: What to Expect". Effectiveness of the project activities will be evaluated through IRB, staff and participant satisfaction surveys,and trending and tracking of adverse events involving human protections issues, i.e. informed consent deviations, violations of Federal and/or IRB regulations, research integrity issues, and other variables to be identified as the programs develop.